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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000040631 |
Receipt No. | R000046344 |
Scientific Title | Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes;Urine metabolomics in patients with diabetic neuropathy |
Date of disclosure of the study information | 2020/06/02 |
Last modified on | 2020/06/02 |
Basic information | ||
Public title | Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes | |
Acronym | Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes;Urine metabolomics in patients with diabetic neuropathy | |
Scientific Title | Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes;Urine metabolomics in patients with diabetic neuropathy | |
Scientific Title:Acronym | Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes | |
Region |
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Condition | ||
Condition | Type 2 diabetes | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | In this study, we targeted patients with type 2 diabetes by measuring CCL11 (eotaxin) and CCL22 (MDC), one of the chemokines, and IL-6 and IL-18, which are one of the cytokines. The purpose of this study is to analyze the clinical significance of the three major complications of patients with diabetic neuropathy, insulin resistance, arteriosclerosis, and other blood sampling . In addition, urinary metabolomics and urinary NGAL are measured, the relationship with diabetic neuropathy is considered, and the aim is to search for new clinical markers that are considered necessary for future treatment of diabetic neuropathy. |
Basic objectives2 | Others |
Basic objectives -Others | The purpose of this study is to analyze the clinical significance of the three major complications mainly of diabetic neuropathy, insulin resistance, arteriosclerosis, and various blood sampling items in type 2 diabetic patients. |
Trial characteristics_1 | |
Trial characteristics_2 | |
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Assessment | |
Primary outcomes | Clinical significance of serum chemokine levels in patient with diabetes and diabetic neuropathy. |
Key secondary outcomes | Time of measurement: early in the morning, fasting
Measurement items (LSI): CCL11 (eotaxin) CCL22 (MDC) IL-6 IL-18 Urine Metabolomics U-NGAL serum: FGF21 BDNF HMW adiponectin IL-33s TNF-R1 & -R2 Relationship with diabetic complications: peripheral neuropathy: staging, nerve conduction test, CVR-R Orthostatic hypotension (Sheron test) Timed up and Go test, Monofilament Nephropathy: eGFR UAE Retinopathy: Stage Relationship with insulin resistance: BMI, InBody, DualScan Relationship with arteriosclerosis: CAVI / ABI FMD carotid IMT Routine examination at admission + IgE + TARC + Beta-hydroxyl-butyrate + M2BPG (i Mac-2 binding protein sugar chain modification isomer), Ca, P, active Vitamin D3 Heart rate variability (HRV): CVR-R, power spectrum analysis (PSA) The severity of diabetic kidney disease Coagulation fibrinolysis system: vWF, d dimer, etc. Arterial stiffness: PWV, CAVI abdominal echo |
Base | |
Study type | Observational |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Type 2 diabetes who have inadequate glycemic control(HbA1c between 6.5 and 12.0%) under medical treatment by dieting and exercise cure and/or drug treatment.
2)Over 20 years old and less than 80 years old 3)Sex unquestioned 4)Patients with no history of cardiovascular disease 5)No treatment or treatment with stable doses of antihypertensive and antiplatelet agents for at least 3 months prior to randomization. 6)The patient who gives a written informed |
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Key exclusion criteria | 1)Type 1 diabetes
2)Liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges) 3)A pregnant woman and/or a woman under breast-feeding 4)Impaired kidney function (serum crearinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women) 5)Diabetic proliferative retinopathy 6)The patients who has an anamnesis of hypersensitivity to the ingredient of a trial drug 7)Patient with intolerance of medical reasons by doctor. |
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Target sample size | 100 |
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Name of lead principal investigator |
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Organization | Dokkyo Medical University | ||||||
Division name | Department of Endocrinology and Metabolism | ||||||
Zip code | 321-0293 | ||||||
Address | 880kita-kobayashi,Mibu,Tochigi321-0293,Japan | ||||||
TEL | 0828-87-2150 | ||||||
jojima@dokkyomed.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Dokkyo Medical University | ||||||
Division name | Department of Endocrinology and Metabolism | ||||||
Zip code | 321-0293 | ||||||
Address | 880kita-kobayashi,Mibu,Tochigi321-0293,Japan | ||||||
TEL | 0282-87-2150 | ||||||
Homepage URL | |||||||
jojima@dokkyomed.ac.jp |
Sponsor | |
Institute | Department of Endocrinology and Metabolism,
Dokkyo Medical University |
Institute | |
Department |
Funding Source | |
Organization | Dokkyo Medical University |
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Category of Funding Organization | Self funding |
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IRB Contact (For public release) | |
Organization | Dokkyo Medical University |
Address | 880kita-kobayashi,Mibu,Tochigi,Japan |
Tel | 0282-87-2275 |
r-kenkyu@dokkyomed.ac.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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Study ID_2 | |
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IND to MHLW |
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Publication of results | Unpublished |
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Recruitment status | Preinitiation | ||||||
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Other related information | cross section study |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046344 |
Research Plan | |
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